RESULTS
Tventy-five patients (92% male, mean age 58.5±14.1 years) were
implanted with the S-ICD device and the AAE using our combined approach.
The most common high infective risk factors were diabetes requiring
insulin treatment (80%) and CKD requiring hemodialysis (48%), with 7
(28%) patients presenting with more than 2 risk factors. More than half
(56%) of the cohort had an underlying ischemic cardiomyopathy, with the
overall left ventricular ejection fraction of the cohort resulting
reduced (27.0 [25.0–35.0]). Table 1 lists baseline
characteristics of the study cohort. All procedures were successful in
deploying the combined system. Peri-procedural characteristics of the
cohort are listed in Table 2
Patients were followed-up for a median of 21 [14–29] months and all
patients included in the study cohort completed at least 1 year
follow-up. A single mild early post-operative hematoma was observed in
the entire cohort (in an anticoagulated patient), that was managed
conservatively, with a spontaneous resolution. No major device related
infections were observed within the first 12 post-procedural months.
Only a single pocket device infection was observed over the entire
follow-up (at eighteen months of follow-up from device implant), that
was managed conservatively and solved with antibiotic therapy. All
device reported correct function at all follow-up visits. During the
entire follow-up, eight patients received appropriate S-ICD therapies.
At last available follow-up, two inappropriate shocks were observed (n=1
T-wave oversensing; n=1 far field) and three patients died (n=2 terminal
heart failure; n=1 active malignancy). Entire follow-up data were
reported in Table 3.